Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain

September 13, 2013 updated by: Pfizer

A Long-Term, Open-Label Safety Study of ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended-Release) Capsules in Subjects With Chronic Moderate to Severe Nonmalignant Pain

Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
467

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Michael Gibson, MD
    • Arizona
      • Phoenix, Arizona, United States, 85027
        • Steven Siwek, MD
      • Phoenix, Arizona, United States, 85032
        • Michael Loes, MD
      • Tempe, Arizona, United States, 85282
        • Allan Soo, MD
      • Tucson, Arizona, United States, 85741
        • Leah Schmidt, DO
    • California
      • Anaheim, California, United States, 92801
        • Steve Sitar, MD
      • Anaheim, California, United States, 92804
        • Robert Burton, MD
      • Bakersfield, California, United States, 93311
        • Arturo Palencia, MD
      • Beverly Hills, California, United States, 90211
        • Adam Karnes, MD
      • Fair Oaks, California, United States, 95628
        • Douglas Haselwood, MD
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Steven Croft, MD
      • Hialeah, Florida, United States, 33013
        • Roberto Rodriquez, MD
      • Jacksonville, Florida, United States, 32257
        • Orlando Florete, MD
      • Kissimmee, Florida, United States, 34741
        • Michael Link, MD
      • Largo, Florida, United States, 33770
        • Miguel Trevino, MD
      • Ormond Beach, Florida, United States, 32174
        • Diego Torres II, MD
      • Plantation, Florida, United States, 33324
        • Martin Hale, MD
      • St. Petersburg, Florida, United States, 33702
        • Margarita Nunez, MD
      • Tampa, Florida, United States, 33613
        • Mary Stedman, MD
    • Georgia
      • Blue Ridge, Georgia, United States, 30513
        • Raymond Tidman, MD
      • Marietta, Georgia, United States, 30060
        • Arnold Weil
      • Marietta, Georgia, United States, 30066
        • Marvin Tark
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Azazuddin Ahmed, MD
      • Peoria, Illinois, United States, 61614
        • Jenecsis Castro-Skoglund, MD
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Steven Elliott, MD
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • John Peppin, DO
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Randall Brewer, MD
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • David Miller, MD
      • Springfield, Massachusetts, United States, 01103
        • Adnan Dahdul, MD
    • Michigan
      • Saginaw, Michigan, United States, 48602
        • Rebecca Baumbach, MD
    • Missouri
      • Florissant, Missouri, United States, 63031
        • Mel Lucas, MD
      • St. Louis, Missouri, United States, 63141
        • Anthony Margherita, MD
    • Montana
      • Missoula, Montana, United States, 59802
        • Randale Sechrest, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • John Jacobson, MD
    • Nevada
      • Henderson, Nevada, United States, 89014
        • James Meli, DO
      • Las Vegas, Nevada, United States, 89106
        • Stephen Miller, MD
      • Las Vegas, Nevada, United States, 89123
        • Vrijendra Kumar, MD
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Christopher Colopinto, MD
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Barbara McGuire, MD
    • New York
      • Mount Vernon, New York, United States, 10550
        • Arthur Elkind, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Patrick Box, MD
      • Winston-Salem, North Carolina, United States, 27103
        • Richard Rauck, MD
      • Winston-Salem, North Carolina, United States, 27103
        • Thomas Littlejohn III, MD
    • Ohio
      • Cincinatti, Ohio, United States, 45242
        • Gregory Gottschlich, MD
      • Cincinnati, Ohio, United States, 45227
        • Bruce Corser, MD
      • Toledo, Ohio, United States, 43623
        • Robert Kalb, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Tanna Shaw, MD
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Joseph Dunn, MD
    • Pennsylvania
      • Tipton, Pennsylvania, United States, 16684
        • Lawrence Levinson, MD
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • William Travis Ellison, MD
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • William Smith, MD
      • Milan, Tennessee, United States, 38358
        • Lee Carter, MD
    • Texas
      • Austin, Texas, United States, 78705
        • Walter Chase, MD
      • Richardson, Texas, United States, 75080
        • Andrew Klymiuk, MD
      • San Antonio, Texas, United States, 78217
        • Francis Burch, MD
      • San Antonio, Texas, United States, 78229
        • Suzanne Gazda, MD
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Webster Lynn, MD
    • Virginia
      • Roanoke, Virginia, United States, 24018
        • Richard Eckert, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject 18-70 years of age
  • Subject agrees to refrain from taking any opioid medications other than study medication during study period.
  • History of chronic moderate to severe pain caused by a nonmalignant condition for at least 3 months prior to baseline

Exclusion Criteria:

  • Subject has a documented history of allergic reaction or clinically significant intolerance to morphine or other opioids, such that treatment with morphine is contraindicated.
  • Subject is pregnant or breast-feeding.
  • Subject is receiving chemotherapy, or has an active malignancy of any type or has been diagnosed with cancer within the past three years (excluding squamous or basal cell carcinoma of the skin).
  • Subject has a documented history of drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse within five years prior to the Baseline Visit.
  • Subject has a Body Mass Index (BMI)>45kg/m2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ALO-01
Doses given once or twice daily
Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
capsules, available dosage strengths 20, 30, 40, 50, 60, 80, and 100 mg morphine sulfate with 4% by weight naltrexone hydrochloride given once or twice daily
Other Names:
  • Embeda

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Subjects With Treatment Emergent Adverse Events
Time Frame: up to 12 months
Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product).
up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain
Time Frame: 12 weeks
Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.
12 weeks
Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain
Time Frame: 52 weeks
Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: James B. Jones, MD, PharmD, Alpharma Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 25, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALO-KNT-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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